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13 May. 2020

Interim Analysis Shows At Least 90% Chance of Statistically Significant Difference in PTSD Symptoms after MDMA-assisted Psychotherapy

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). This is the best-case scenario for an interim analysis, and suggests that MAPS’ research program is on track for approval by the U.S. Food and Drug Administration (FDA).

The analysis was conducted by an independent Data Monitoring Committee, which reviewed the results from the first 60 out of 100 participants. The analysis revealed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated, and that the trial will not require additional participants beyond the first 100. The interim analysis was approved by the FDA as part of MAPS’ Statistical Analysis Plan approved by the FDA.

The results strongly suggest that the FDA made the right decision in granting MAPS both (1) Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD, which accelerates the clinical trial process and acknowledges MDMA-assisted psychotherapy as a potentially significant advance over currently available treatments for PTSD, and (2) Expanded Access, which will allow some patients early access to MDMA-assisted psychotherapy for PTSD prior to approval.

MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.

For more information and to read the entire press release, please click here.